Lupin gets USFDA nod for opioid analgesic tablets
NEW DELHI, June 14: Drug firm Lupin has received final approval from the US health regulator for its Oxycodone Hydrochloride tablets used in case of severe pain.
The company has received final approval from the United States Food and Drug Administration (USFDA) to market its Oxycodone Hydrochloride tablets USP, in the strengths of 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, Lupin said in a statement.
The company’s tablets are generic version of Mallinckrodt Inc’s Roxicodone tablets, it added.
The tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, Lupin said.
“Roxicodonet tablets had US sales of USD 344 million as per IMS MAT March 2017”, it added.
The company currently has 151 product filings pending approval with USFDA, Lupin said.
(PTI)
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